[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"fda-warning-letter-mesquite-gourmet-llc-731021-08042026":3,"fda-latest-sync-dates":30},{"id":4,"letter_id":5,"action_type":6,"firm_name":7,"fei_number":8,"issuing_office":9,"subject":10,"posted_date":11,"action_taken_date":12,"response_letter_date":8,"closeout_date":8,"case_status":13,"letter_url":14,"reference_number":8,"marcs_cms_no":15,"product_type":16,"delivery_method":17,"recipient_name":18,"recipient_title":8,"body_html":19,"body_text":20,"body_fetched_at":21,"medical_device_id":8,"raw":22,"created_at":28,"updated_at":29},21641,"mesquite-gourmet-llc-731021-08042026","Warning Letter","Mesquite Gourmet LLC",null,"Office of Inspections and Investigations","Foreign Supplier Verification Program (FSVP)","2026-09-01","2026-08-04","Issued","https:\u002F\u002Fwww.fda.gov\u002Finspections-compliance-enforcement-and-criminal-investigations\u002Fwarning-letters\u002Fmesquite-gourmet-llc-731021-08042026","731021","Food & Beverages","Via Express Delivery","Mr. Oscar Andrade","\n\n                            \n                            \n                            \n                            \n                                              \n  \n \n\n                 \n\n  \u003Chr>\n \n\n\u003Cdiv class=\"inset-column\">\n  \u003Cdl class=\"lcds-description-list--grid\">\n\n              \u003Cdt class=\"cell-1_1\">Delivery Method:\u003C\u002Fdt> \n        \u003Cdd class=\"cell-2_1\">Via Express Delivery\n                                                                                                                                                                                                                                                                                                                                                                                                                              \u003C\u002Fdd>\n      \n      \n              \u003Cdt class=\"cell-1_3\">Product:\u003C\u002Fdt> \n        \u003Cdd class=\"cell-2_3\">Food & Beverages                          \n            \n            \n            \n            \n            \n            \n            \n             \n            \n            \n            \n              \n            \n            \n            \u003C\u002Fdd>\n      \n          \u003C\u002Fdl>\n  \u003C\u002Fdiv>            \n\n\n\u003Chr>\n\n\u003Cdiv class=\"row inset-column\">\n  \u003Cdiv class=\"col-xs-12 col-md-6\">\n    \u003Cdl class=\"\">\n\n        \u003Cdt>Recipient:\u003C\u002Fdt>\n\n                      \u003Cdd>\n  \u003Cdiv class=\"field field--name-field-recipient-name field--type-string field--label-above\">\n    \u003Cdiv class=\"field--label\">Recipient Name\u003C\u002Fdiv>\n              \u003Cdiv class=\"field--item\">Mr. Oscar Andrade\u003C\u002Fdiv>\n          \u003C\u002Fdiv>\n\u003C\u002Fdd>\n                                \u003Cdd>\n  \u003Cdiv class=\"field field--name-field-recipient-title field--type-string field--label-above\">\n    \u003Cdiv class=\"field--label\">Recipient Title\u003C\u002Fdiv>\n              \u003Cdiv class=\"field--item\">Owner and General Manager \u003C\u002Fdiv>\n          \u003C\u002Fdiv>\n\u003C\u002Fdd>\n          \n            \u003Cdd>Mesquite Gourmet LLC \u003C\u002Fdd>\n\n          \n                      \u003Cdd>\u003Cp class=\"address\" translate=\"no\">\u003Cspan class=\"address-line1\">9901 I.H. 10 West, Suite 800\u003C\u002Fspan>\u003Cbr>\n\u003Cspan class=\"locality\">San Antonio\u003C\u002Fspan>, \u003Cspan class=\"administrative-area\">TX\u003C\u002Fspan> \u003Cspan class=\"postal-code\">78230-2292\u003C\u002Fspan>\u003Cbr>\n\u003Cspan class=\"country\">United States\u003C\u002Fspan>\u003C\u002Fp>\u003C\u002Fdd>\n          \n          \n            \n            \u003Cdd>\u003C!-- Loop this field. For FDA Office content type. Display the Other contact channel is a dd span with an icon-->\n\n    \u003C\u002Fdd>\u003Cdd>\u003Cspan class=\"fa fa-envelope\" aria-hidden=\"true\">\u003C\u002Fspan>\u003Ca href=\"mailto:(b)(6), (b)(7)(C)\"> (b)(6), (b)(7)(C)\u003C\u002Fa>\u003C\u002Fdd>\n\n          \n    \u003C\u002Fdl>\n  \u003C\u002Fdiv>            \n\n       \u003Cdiv class=\"col-xs-12 col-md-6\">\n    \u003Cdl class=\"\">\n          \n          \u003Cdt>Issuing Office:\u003C\u002Fdt>\n        \n         \n          \u003Cdd>Office of Inspections and Investigations\u003C\u002Fdd>\n        \n         \n          \u003Cdd>\u003Cp class=\"address\" translate=\"no\">\u003Cspan class=\"country\">United States\u003C\u002Fspan>\u003C\u002Fp>\u003C\u002Fdd>\n        \n        \n        \n        \n        \n    \u003C\u002Fdl>\n    \u003Cdl class=\"\"> \n      \n    \u003C\u002Fdl>\n  \u003C\u002Fdiv>  \n      \n\u003C\u002Fdiv>\n\n \n\n \n\n\u003Chr>\n\n\u003Cp>August 04, 2026\u003C\u002Fp>\u003Cp class=\"text-align-center\">\u003Cstrong>WARNING LETTER\u003C\u002Fstrong>\u003C\u002Fp>\u003Cp class=\"text-align-center\">Re: CMS 731021\u003C\u002Fp>\u003Cp>Dear Mr. Oscar Andrade:\u003C\u002Fp>\u003Cp>On 05\u002F04\u002F2026-05\u002F15\u002F2026, the Food and Drug Administration (FDA) conducted a Foreign Supplier Verification Program (FSVP) inspection of Mesquite Gourmet LLC located at 9901 I.H. 10 West, Suite 800, San Antonio, TX 78230-2292. We also conducted inspections on 07\u002F19\u002F2023-07\u002F20\u002F2023 and 10\u002F15\u002F2024-10\u002F17\u002F2024. These inspections were conducted to determine compliance with the requirements of section 805 of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 384a) and the implementing FSVP regulation in 21 CFR part 1, subpart L.\u003C\u002Fp>\u003Cp>The FSVP regulation requires that importers perform certain risk-based activities to verify that human and\u002For animal food they import into the United States has been produced in a manner that meets applicable U.S. food safety standards. You may find information relating to the FSVP regulation and your responsibilities to comply with the regulation through links in FDA’s FSVP web page at https:\u002F\u002Fwww.fda.gov\u002Ffood\u002Ffood-safety-modernization-act-fsma\u002Ffsma-final-rule-foreign-supplier-verification-programs-fsvp-importers-food-humans-and-animals.\u003C\u002Fp>\u003Cp>During the most recent inspection, we found that you are not in compliance with the requirements of 21 CFR part 1, subpart L for the foods from the foreign suppliers indicated in the attached list. Because of these significant violations, you are not in compliance with section 805 of the FD&C Act.\u003C\u002Fp>\u003Cp>At the conclusion of the inspection, our investigator provided you with a Form FDA 483a, FSVP Observations.\u003C\u002Fp>\u003Cp>We acknowledge receipt of your response, dated 05\u002F26\u002F2026, in which you requested an additional six months to implement your FSVPs for all your imported foods.\u003C\u002Fp>\u003Cp>Your significant violations of the FSVP regulation are as follows:\u003C\u002Fp>\u003Cp>You did not develop, maintain, and follow an FSVP as required by section 805 of the FD&C Act and 21 CFR 1.502(a). Specifically, you did not develop an FSVP for the foods you import from the foreign suppliers indicated in the attached list, including each of the following foods:\u003C\u002Fp>\u003Cul>\u003Cli>Fresh Anaheim peppers from \u003Cstrong>(b)(4)\u003C\u002Fstrong>\u003C\u002Fli>\u003Cli>Fresh habanero peppers from \u003Cstrong>(b)(4)\u003C\u002Fstrong>\u003C\u002Fli>\u003Cli>Fresh jalapeno peppers from \u003Cstrong>(b)(4)\u003C\u002Fstrong>\u003C\u002Fli>\u003C\u002Ful>\u003Cp>In your response on 05\u002F26\u002F2026 you provided the following documents: Qualified Individual Certificates, a statement your firm no longer has a commercial relationship with \u003Cstrong>(b)(4)\u003C\u002Fstrong>, a statement your firm no longer has a commercial relationship with \u003Cstrong>(b)(4)\u003C\u002Fstrong>, FSVP Policies SOP, Company Overview, FSVP for \u003Cstrong>(b)(4)\u003C\u002Fstrong>, FSVP for \u003Cstrong>(b)(4)\u003C\u002Fstrong> and Formal Request for Extension of Time to Submit Remaining FSVP Documentation. You stated that you request a six-month extension to submit your firm’s remaining FSVPs. However, it is not clear how these documents would apply to your FSVP program, and you did not explain how they would apply to your FSVP program.\u003C\u002Fp>\u003Cp>You import fresh produce that may be considered “covered produce” as defined in 21 CFR 112.3. If after review of the fresh produce that you import you determine that you are an importer of covered produce, you must have an FSVP that demonstrates that your supplier is producing the food in compliance with processes and procedures that provide at least the same level of public health protection as those required under section 419 of the FD&C Act (21 U.S.C. 350h) (regarding standards for produce safety) and the implementing regulations in the Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption (21 CFR part 112).\u003C\u002Fp>\u003Cp>The above violations are not intended to be an all-inclusive list of violations of the FSVP requirements. It is your responsibility to ensure that you are in compliance with section 805 of the FD&C Act and the implementing regulation in 21 CFR part 1, subpart L.\u003C\u002Fp>\u003Cp>This letter notifies you of our concerns and provides you an opportunity to address them. If you do not adequately address this matter, we may take further action. For instance, we may take action under section 801(a)(3) of the FD&C Act (21 U.S.C. 381(a)(3)) to refuse admission of the food you import for which you appear to be in violation of section 805. We may place the foods you import into the United States on detention without physical examination (DWPE) when you import the foods. You can find DWPE information relating to FSVP in Import Alert # 99-41 at http:\u002F\u002Fwww.accessdata.fda.gov\u002Fcms_ia\u002Fialist.html. In addition, the importation or offering for importation into the United States of an article of food without the importer having an FSVP that meets the requirements of section 805 of the FD&C Act or the FSVP regulation is prohibited under section 301(zz) of the FD&C Act (21 U.S.C. 331(zz)).\u003C\u002Fp>\u003Cp>You should respond in writing within fifteen (15) working days from your receipt of this letter. Your response should address the specific things you are doing to correct any violations. You should include in your response documentation and information that would assist us in evaluating your corrections (e.g., documentation of changes you made, such as a copy of your FSVP, records to demonstrate implementation of your FSVP), and any additional information that you wish to supply relevant to your compliance with the FSVP regulation. If you believe that you are not in violation of the FD&C Act, include your reasoning and any supporting information for our consideration. If you cannot complete all corrections within 15 working days, you should explain the reason for your delay and state when you will correct any remaining violations.\u003C\u002Fp>\u003Cp>Please send your reply to Food and Drug Administration, Attention: Zumera Ajani, Compliance Officer, Division of Southwest Imports, 1201 Main Street, Suite 7200, Dallas, TX 75202. If you have any questions regarding this letter, or wish to send your response electronically, you may contact Zumera Ajani via email at Zumera.Ajani@fda.hhs.gov. Please reference CMS # 731021 on any documents or records you provide to us and on the subject line of any email correspondence you send to us.\u003C\u002Fp>\u003Cp>Sincerely,\u003Cbr>\u002FS\u002F\u003C\u002Fp>\u003Cp>Todd W Cato\u003Cbr>Program Division Director\u003Cbr>Division of Southwest Imports\u003C\u002Fp>\n\n\u003C!--BEGIN QUALTRICS WEBSITE FEEDBACK SNIPPET-->\n\u003C!--BEGIN QUALTRICS WEBSITE FEEDBACK SNIPPET-->\n\n\n\n              \n                                            \n              \n            ","Delivery Method:\n\nVia Express Delivery\n\nProduct:\n\nFood & Beverages\n\nRecipient:\n\nRecipient Name\n\nMr. Oscar Andrade\n\nRecipient Title\n\nOwner and General Manager\n\nMesquite Gourmet LLC\n\n9901 I.H. 10 West, Suite 800\n\nSan Antonio, TX 78230-2292\n\nUnited States\n\n(b)(6), (b)(7)(C)\n\nIssuing Office:\n\nOffice of Inspections and Investigations\n\nUnited States\n\nAugust 04, 2026\nWARNING LETTER\nRe: CMS 731021\nDear Mr. Oscar Andrade:\nOn 05\u002F04\u002F2026-05\u002F15\u002F2026, the Food and Drug Administration (FDA) conducted a Foreign Supplier Verification Program (FSVP) inspection of Mesquite Gourmet LLC located at 9901 I.H. 10 West, Suite 800, San Antonio, TX 78230-2292. We also conducted inspections on 07\u002F19\u002F2023-07\u002F20\u002F2023 and 10\u002F15\u002F2024-10\u002F17\u002F2024. These inspections were conducted to determine compliance with the requirements of section 805 of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 384a) and the implementing FSVP regulation in 21 CFR part 1, subpart L.\nThe FSVP regulation requires that importers perform certain risk-based activities to verify that human and\u002For animal food they import into the United States has been produced in a manner that meets applicable U.S. food safety standards. You may find information relating to the FSVP regulation and your responsibilities to comply with the regulation through links in FDA’s FSVP web page at https:\u002F\u002Fwww.fda.gov\u002Ffood\u002Ffood-safety-modernization-act-fsma\u002Ffsma-final-rule-foreign-supplier-verification-programs-fsvp-importers-food-humans-and-animals.\nDuring the most recent inspection, we found that you are not in compliance with the requirements of 21 CFR part 1, subpart L for the foods from the foreign suppliers indicated in the attached list. Because of these significant violations, you are not in compliance with section 805 of the FD&C Act.\nAt the conclusion of the inspection, our investigator provided you with a Form FDA 483a, FSVP Observations.\nWe acknowledge receipt of your response, dated 05\u002F26\u002F2026, in which you requested an additional six months to implement your FSVPs for all your imported foods.\nYour significant violations of the FSVP regulation are as follows:\nYou did not develop, maintain, and follow an FSVP as required by section 805 of the FD&C Act and 21 CFR 1.502(a). Specifically, you did not develop an FSVP for the foods you import from the foreign suppliers indicated in the attached list, including each of the following foods:\nFresh Anaheim peppers from (b)(4)\nFresh habanero peppers from (b)(4)\nFresh jalapeno peppers from (b)(4)\nIn your response on 05\u002F26\u002F2026 you provided the following documents: Qualified Individual Certificates, a statement your firm no longer has a commercial relationship with (b)(4), a statement your firm no longer has a commercial relationship with (b)(4), FSVP Policies SOP, Company Overview, FSVP for (b)(4), FSVP for (b)(4) and Formal Request for Extension of Time to Submit Remaining FSVP Documentation. You stated that you request a six-month extension to submit your firm’s remaining FSVPs. However, it is not clear how these documents would apply to your FSVP program, and you did not explain how they would apply to your FSVP program.\nYou import fresh produce that may be considered “covered produce” as defined in 21 CFR 112.3. If after review of the fresh produce that you import you determine that you are an importer of covered produce, you must have an FSVP that demonstrates that your supplier is producing the food in compliance with processes and procedures that provide at least the same level of public health protection as those required under section 419 of the FD&C Act (21 U.S.C. 350h) (regarding standards for produce safety) and the implementing regulations in the Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption (21 CFR part 112).\nThe above violations are not intended to be an all-inclusive list of violations of the FSVP requirements. It is your responsibility to ensure that you are in compliance with section 805 of the FD&C Act and the implementing regulation in 21 CFR part 1, subpart L.\nThis letter notifies you of our concerns and provides you an opportunity to address them. If you do not adequately address this matter, we may take further action. For instance, we may take action under section 801(a)(3) of the FD&C Act (21 U.S.C. 381(a)(3)) to refuse admission of the food you import for which you appear to be in violation of section 805. We may place the foods you import into the United States on detention without physical examination (DWPE) when you import the foods. You can find DWPE information relating to FSVP in Import Alert # 99-41 at http:\u002F\u002Fwww.accessdata.fda.gov\u002Fcms_ia\u002Fialist.html. In addition, the importation or offering for importation into the United States of an article of food without the importer having an FSVP that meets the requirements of section 805 of the FD&C Act or the FSVP regulation is prohibited under section 301(zz) of the FD&C Act (21 U.S.C. 331(zz)).\nYou should respond in writing within fifteen (15) working days from your receipt of this letter. Your response should address the specific things you are doing to correct any violations. You should include in your response documentation and information that would assist us in evaluating your corrections (e.g., documentation of changes you made, such as a copy of your FSVP, records to demonstrate implementation of your FSVP), and any additional information that you wish to supply relevant to your compliance with the FSVP regulation. If you believe that you are not in violation of the FD&C Act, include your reasoning and any supporting information for our consideration. If you cannot complete all corrections within 15 working days, you should explain the reason for your delay and state when you will correct any remaining violations.\nPlease send your reply to Food and Drug Administration, Attention: Zumera Ajani, Compliance Officer, Division of Southwest Imports, 1201 Main Street, Suite 7200, Dallas, TX 75202. If you have any questions regarding this letter, or wish to send your response electronically, you may contact Zumera Ajani via email at Zumera.Ajani@fda.hhs.gov. Please reference CMS # 731021 on any documents or records you provide to us and on the subject line of any email correspondence you send to us.\nSincerely,\n\u002FS\u002F\nTodd W Cato\nProgram Division Director\nDivision of Southwest Imports","2026-09-07T05:14:32.902+00:00",[23,24,25,9,26,27,27,27],"\u003Ctime datetime=\"2026-09-01T04:00:00Z\">09\u002F01\u002F2026\u003C\u002Ftime>\n","\u003Ctime datetime=\"2026-08-04T04:00:00Z\">08\u002F04\u002F2026\u003C\u002Ftime>\n","\u003Ca href=\"\u002Finspections-compliance-enforcement-and-criminal-investigations\u002Fwarning-letters\u002Fmesquite-gourmet-llc-731021-08042026\">Mesquite Gourmet LLC \u003C\u002Fa>","Foreign Supplier Verification Program (FSVP)\u003Cbr \u002F>\r\n","","2026-09-07T05:14:13.57002+00:00","2026-09-07T05:14:32.961161+00:00",{"510k":31,"classification":32,"enforcement":33,"event":34,"event_backfill":35,"pma":36,"warning_letter":37},"2026-09-07T05:11:19.067+00:00","2026-09-07T05:11:15.53+00:00","2026-09-07T05:11:16.99+00:00","2026-09-07T05:18:11.694+00:00","2026-09-07T05:17:28.839+00:00","2026-09-07T05:11:20.665+00:00","2026-09-07T05:15:19.69+00:00"]